BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIQ CVX DIAGNOSTIC ULTRASOUND SYSTEM

    MDR report key: 22786197 · Received August 12, 2025

    Report

    Report Number
    3019216-2025-000276
    Event Type
    Malfunction
    Date Received
    August 12, 2025
    Date of Event
    July 30, 2025
    Report Date
    October 8, 2025
    Manufacturer
    PHILIPS ULTRASOUND
    Product Code
    IYN
    UDI-DI
    00884838097933
    PMA / PMN Number
    K132304
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A QUALIFIED R&D ENGINEER EVALUATED THE TRANSDUCER BASED ON THE CUSTOMER COMPLAINT. VISUAL INSPECTION FOUND POTENTIAL THIRD-PARTY REPAIR AND CUSTOMER MISUSE DUE TO THE BITE MARKS, FLUID INGRESS, AND THIRD-PARTY LABEL. HOWEVER, THE REPORTED ISSUE WAS NOT REPRODUCIBLE. THERE WAS NO INDICATION OF EITHER NON-CONFORMING MATERIAL FROM SHIPMENT, AND NO INDICATION OF DESIGN ANOMALY REQUIRING FURTHER ACTION. THE CUSTOMER'S COMPLAINT WAS ADDRESSED BY REPLACING THE TRANSDUCER. AFTER REPLACING THE TRANSDUCER, ALL TRANSDUCER AND SYSTEM FUNCTIONAL TESTS PASSED AND NO ADDITIONAL REPAIR OR ANALYSIS ACTION WAS REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THE X7-8T TEE TRANSDUCER WOULD NOT ARTICULATE DURING USE WITH AN EPIQ CVX ULTRASOUND SYSTEM. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE FIELD SERVICE ENGINEER REPLACED THE TRANSDUCER TO RESOLVE THE ISSUE. AN INVESTIGATION IS UNDERWAY TO DETERMINE THE ROOT CAUSE OF THE ISSUE. RESULTS OF THE INVESTIGATION WILL BE INCLUDED IN A FOLLOW UP REPORT UPON ITS COMPLETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1378831 EPIQ CVX DIAGNOSTIC ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN PHILIPS ULTRASOUND 795231 00884838097933

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown